Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003004
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
An Open-Label Non-Randomized Phase I Study of the Protein Kinase C Inhibitor Flavopiridol Administered in Combination With Paclitaxel in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy with paclitaxel and cisplatin plus flavopiridol in treating patients who have refractory or recurrent solid tumors
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy with paclitaxel and cisplatin plus flavopiridol in treating patients who have refractory or recurrent solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of flavopiridol when administered in combination with paclitaxel and cisplatin in patients with refractory adult solid tumors II Investigate the clinical pharmacokinetics of intravenous flavopiridol when administered in combination with paclitaxel in these patients III Obtain preliminary data on the therapeutic activity of flavopiridol when administered in combination with paclitaxel in these patients IV Evaluate surrogate markers of activity such as inhibition of PKC or CDK1 in these patients
OUTLINE This is an open label dose escalation study Patients receive paclitaxel IV over 3 hours on day 1 On day 2 patients receive cisplatin IV over 20 minutes followed by a 24 hour infusion of flavopiridol Courses are repeated every 21 days in the absence of disease progression or unacceptable toxicity Sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin Dose escalation in cohorts of 3-6 patients each continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed every 6 weeks
PROJECTED ACCRUAL Approximately 46-73 patients will be accrued for this study within 6 more months
OUTLINE This is an open label dose escalation study Patients receive paclitaxel IV over 3 hours on day 1 On day 2 patients receive cisplatin IV over 20 minutes followed by a 24 hour infusion of flavopiridol Courses are repeated every 21 days in the absence of disease progression or unacceptable toxicity Sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin Dose escalation in cohorts of 3-6 patients each continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed every 6 weeks
PROJECTED ACCRUAL Approximately 46-73 patients will be accrued for this study within 6 more months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T96-0091 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065571 | REGISTRY | None | None |